BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATION STEALTHSTATION TOOL

    MDR report key: 7916770 · Received September 27, 2018

    Report

    Report Number
    1723170-2018-04925
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    March 8, 2018
    Report Date
    January 11, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    PMA / PMN Number
    K983670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLAMP WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT THE CLAMP WAS RETURNED AND ATTACHED TO AN INSTRUMENT. THE CLAMP WAS ABLE TO BE REMOVED. THE ADJUSTMENT SCREW HEX HEAD WAS SLIGHT ROUNDED OUT WITH MANY TOOL MARKS AROUND THE HEAD, BUT THE CLAMP WAS OTHERWISE FUNCTIONAL. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. B5) FOR INFORMATION REGARDING THE FIRST DAMAGED INSTRUMENT PLEASE REFER TO MANUFACTURER REPORT # 1723170-2018-04924. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION: 510K NUMBER K983670. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING 4 DAMAGED INSTRUMENTS. IT WAS UNKNOWN IF THEY COULD BE VERIFIED OR NOT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755774 NAVIGATION STEALTHSTATION TOOL ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 961-578 160201

    Patients

    Seq Age Sex Outcome Treatment
    1